Altamira Therapeutics Announces Certification of Bentrio Nasal Spray under Medical Device Regulation
Altamira Therapeutics (OTCQB:CYTOF) announced on November 20, 2025 that associate Altamira Medica obtained EU Medical Device Regulation (MDR) certification for Bentrio nasal spray. The certification confirms conformity with the EU's stricter safety, performance and quality requirements for medical devices and is a prerequisite for legally commercializing Bentrio in EU member states.
The announcement notes Bentrio was previously launched under the MDD as a Class I device in 2021 and was up‑classified to Class IIa under MDR, which required clinical trials, independent Notified Body certification and substantial investments by Medica. The company says MDR status also supports regulatory filings outside the EU and aids the product's international growth strategy.
Altamira Therapeutics (OTCQB:CYTOF) ha comunicato il 20 novembre 2025 che la consociata Altamira Medica ha ottenuto la certificazione EU Medical Device Regulation (MDR) per lo spray nasale Bentrio. La certificazione conferma la conformità ai requisiti europei più stringenti di sicurezza, prestazioni e qualità per i dispositivi medici ed è un prerequisito per commercializzare legalmente Bentrio negli Stati membri dell'UE.
La comunicazione segnala che Bentrio era stato lanciato in precedenza ai sensi della MDD come dispositivo di Classe I nel 2021 e che è stato elevato a Classe IIa secondo MDR, il che ha richiesto trial clinici, certificazione indipendente da parte dell'Notified Body e significativi investimenti da parte di Medica. L'azienda afferma che lo status MDR supporta anche le presentazioni regolatorie al di fuori dell'UE e facilita la crescita internazionale del prodotto.
Altamira Therapeutics (OTCQB:CYTOF) anunció el 20 de noviembre de 2025 que la socia Altamira Medica obtuvo la certificación de la Regulación de Dispositivos Médicos de la UE (MDR) para el spray nasal Bentrio. La certificación confirma la conformidad con los estrictos requisitos de seguridad, rendimiento y calidad de la UE para dispositivos médicos y es un requisito previo para comercializar legalmente Bentrio en los estados miembros de la UE.
La anuncio señala que Bentrio fue lanzado previamente bajo la MDD como un dispositivo de Clase I en 2021 y fue reclasificado a Clase IIa conforme a MDR, lo que requirió ensayos clínicos, certificación independiente por un Organismo Notificado y inversiones significativas por parte de Medica. La empresa dice que el estatus MDR también respalda las presentaciones regulatorias fuera de la UE y ayuda a la estrategia de crecimiento internacional del producto.
알타미라 테라퓨틱스(OTCQB:CYTOF)가 2025년 11월 20일에 자회사인 Altamira Medica가 Bentrio 코 비강 스프레이에 대해 EU 의료기기 규정(MDR) 인증을 획득했다고 발표했습니다. 인증은 의료기기에 대한 EU의 더 엄격한 안전성, 성능 및 품질 요건을 충족함을 확인하며 Bentrio를 EU 회원국에서 합법적으로 판매하기 위한 선행 조건입니다.
발표에 따르면 Bentrio는 2021년 MDD 하에서 1등급(Class I) 기기로 출시되었고 MDR에 따라 Class IIa로 상향되었으며, 이는 임상시험, 독립적 공인기관(Notified Body) 인증 및 Medica의 상당한 투자를 필요로 했습니다. 회사는 MDR 상태가 EU 밖의 규제 제출도 지원하고 제품의 국제적 성장 전략을 돕는다고 말합니다.
Altamira Therapeutics (OTCQB:CYTOF) a annoncé le 20 novembre 2025 que sa société associée Altamira Medica a obtenu la certification de la réglementation européenne sur les dispositifs médicaux (MDR) pour le spray nasal Bentrio. La certification confirme la conformité aux exigences plus strictes de sécurité, de performance et de qualité de l'UE pour les dispositifs médicaux et constitue une condition préalable à la commercialisation légale de Bentrio dans les États membres de l'UE.
La annonce indique que Bentrio avait été lancé précédemment sous la MDD en tant que dispositif de classe I en 2021 et a été reclassé en Classe IIa selon la MDR, ce qui a nécessité des essais cliniques, une certification indépendante par un organisme notifié et des investissements importants de Medica. La société affirme que le statut MDR soutient également les dépôts réglementaires en dehors de l'UE et aide la stratégie de croissance internationale du produit.
Altamira Therapeutics (OTCQB:CYTOF) gab am 20. November 2025 bekannt, dass die Tochtergesellschaft Altamira Medica die EU-Medizinprodukte-Verordnung (MDR) Zertifizierung für das Nasenspray Bentrio erhalten hat. Die Zertifizierung bestätigt die Konformität mit den strengeren Sicherheits-, Leistungs- und Qualitätsanforderungen der EU für Medizinprodukte und ist eine Voraussetzung für die rechtliche Vermarktung von Bentrio in den EU-Mitgliedstaaten.
Die Ankündigung weist darauf hin, dass Bentrio zuvor unter der MDD als Klasse-I-Gerät im Jahr 2021 eingeführt wurde und gemäß MDR auf Klasse IIa hochgestuft wurde, was klinische Studien, unabhängige Zertifizierung durch ein benanntes Prüfunternehmen (Notified Body) und erhebliche Investitionen von Medica erforderte. Das Unternehmen sagt, dass der MDR-Status auch regulatorische Einreichungen außerhalb der EU unterstützt und die internationale Wachstumsstrategie des Produkts fördert.
Altamira Therapeutics (OTCQB:CYTOF) أعلنت في 20 نوفمبر 2025 أن الشركة التابعة Altamira Medica حصلت على شهادة تنظيم الأجهزة الطبية للاتحاد الأوروبي MDR لرشّة الأنف Bentrio. تؤكد الشهادة الت conformidad مع المتطلبات الأوروبية الأكثر صرامة فيما يخص السلامة والأداء والجودة للأجهزة الطبية وهي شرط مسبق لتسويق Bentrio بشكل قانوني في الدول الأعضاء في الاتحاد الأوروبي.
تشير الإعلان إلى أن Bentrio كان قد أُطلق سابقاً بموجب MDD كجهاز من الفئة I في 2021 وتم تصنيفه إلى الدرجة IIa وفق MDR، وهو ما استلزم تجارب سريرية، وشهادة من جهة مُعلَنة Notified Body مستقلة، واستثمارات كبيرة من Medica. تقول الشركة إن وضع MDR يدعم أيضاً الطلبات التنظيمية خارج الاتحاد الأوروبي ويساعد في استراتيجية النمو الدولي للمنتج.
- MDR certification obtained for Bentrio on November 20, 2025
- Enables commercialization of Bentrio in EU member states
- Supports international filings as MDR serves as external reference
- Clinical trials completed to meet MDR Class IIa requirements
- Up‑classification to Class IIa increased regulatory requirements
- Substantial efforts and investments required to achieve MDR compliance
Conformity with stringent new EU regulations for medical devices confirmed
Allows for commercialization of Bentrio in EU member states; facilitates regulatory approval in various other countries
Major milestone in international growth strategy
HAMILTON, BERMUDA / ACCESS Newswire / November 20, 2025 / Altamira Therapeutics Ltd. ("Altamira" or the "Company") (OTCQB:CYTOF), a company dedicated to developing and supplying nucleic acid delivery technology for partners in biotech and pharma, today announced that its associate company Altamira Medica ("Medica") obtained certification of its Bentrio® nasal spray under the European Union's Medical Device Regulation (MDR). Bentrio is a drug-free, preservative-free nasal spray for protection against airborne allergens which is commercialized by Medica through a network of marketing and distribution partners.
"The MDR certification represents a major milestone for our innovative Bentrio nasal spray as it is a prerequisite for commercializing the product in the European Union and beyond," commented Thomas Meyer, Medica's Chairman and CEO. "The certification declares Bentrio's conformity with the EU's new rigorous requirements for demonstrating and ensuring the safety, performance and quality of medical devices. Further, it serves as a key reference for certain regulatory agencies outside the EU, thus facilitating marketing clearance in various countries. We look forward to moving forward with our growth strategy with Bentrio in close collaboration with our international marketing and distribution partners."
The EU started to implement the MDR framework in 2021, thus gradually replacing the Medical Device Directive (MDD). Bentrio was launched in certain EU markets in 2021 as a "Class I" medical device under MDD, based on a self-declaration of conformity. Under MDR, nasal sprays such as Bentrio are considered "Class IIa" medical devices, implying additional regulatory requirements. The new regulations, together with the up-classification, required substantial efforts and investments by Medica, including the conduct of clinical trials and independent certification by a designated Notified Body.
About Bentrio
Bentrio is an "over the counter" drug-free nasal spray for personal protection against airborne allergens and, where approved, against airborne viruses. Upon application into the nose, Bentrio forms a protective gel layer on the nasal mucosa. This thin film is designed to prevent the contact of airborne particles with cells; in addition, the composition serves to bind such particles and help with their discharge. The efficacy and safety of Bentrio have been demonstrated in a total of four clinical trials, of which the largest one ("NASAR" study) enrolled 100 patients suffering from seasonal allergic rhinitis. In NASAR, participants self-administered either Bentrio or saline nasal spray for two weeks 3 times per day. The study showed a statistically significant reduction in the mean daily reflective Total Nasal Symptom Score (rTNSS) for Bentrio compared to saline (p = 0.013), as well as a statistically highly significant improvement in health-related quality of life (Rhinoconjunctivitis Quality of Life Questionnaire, p < 0.001) and superior global ratings of efficacy by patients and investigators alike (p < 0.001). In addition, Bentrio showed good safety and tolerability, similar to saline controls, and fewer Bentrio treated patients used relief medication and more of them enjoyed symptom-free days compared to saline treatment. For more information, visit: www.bentrio.com
About Altamira Therapeutics
Altamira Therapeutics is developing and supplying peptide-based nanoparticle technologies for efficient nucleic acid delivery (xPhore™ platform). The versatile delivery platform is suited for different nucleic acid modalities, including siRNA, mRNA, circRNA, as well as DNA, and made available to pharma or biotech companies through out-licensing. The Company has two proprietary flagship programs based on xPhore and siRNA payloads: AM-401 for KRAS driven cancer and AM-411 for rheumatoid arthritis, both in preclinical development beyond in vivo proof of concept. In addition, Altamira holds a
Forward-Looking Statements
This press release may contain statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Altamira's strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may", "might", "will", "should", "expects", "plans", "anticipates", "believes", "estimates", "predicts", "projects", "potential", "outlook" or "continue", or the negative of these terms or other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include but are not limited to the clinical utility of Altamira's product candidates, the timing or likelihood of regulatory filings and approvals, Altamira's intellectual property position and Altamira's financial position. These risks and uncertainties also include, but are not limited to, those described under the caption "Risk Factors" in Altamira's Annual Report on Form 20-F for the year ended December 31, 2024, and in Altamira's other filings with the Securities Exchange Commission ("SEC"), which are available free of charge on the SEC's website at: www.sec.gov. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated. All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Altamira or to persons acting on behalf of Altamira are expressly qualified in their entirety by reference to these risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and Altamira does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law.
Investor Contact:
SOURCE: Altamira Therapeutics Ltd.
View the original press release on ACCESS Newswire
FAQ
What does Altamira Therapeutics (CYTOF) announce on November 20, 2025 about Bentrio?
How does MDR certification affect Bentrio's ability to sell in EU markets?
Why was Bentrio reclassified to Class IIa under MDR and what did that require?
Will the MDR certification help Bentrio gain approval outside the EU?
What investor implications does the Bentrio MDR certification have for CYTOF shareholders?
When was Bentrio originally launched in EU markets and under which directive?
